EUROPEAN UNION (EU) – JUNE NEWSLETTER
Guidance document on the implementation of EU Product Rules 2022 | 29 June 2022
The ‘Blue Guide’ on EU product rules 2022 (Document Number (2022/C 247/01). This June newsletter guidance discusses both non-food and non-agricultural products, referred to as products for use by consumers or professionals.
It applies to medical and in-vitro diagnostic devices that comply with Regulation (EU) 2017/745 and Regulation (EU) 2017/746. It covers various topics such as the actors in the supply chain, product requirements and market surveillance of products in the EU market.
Notice to manufacturers to ensure timely compliance with MDR requirement | 13 June 2022
The regulatory framework for medical devices and in vitro diagnostic medical devices (IVD) has altered dramatically after the introduction of Regulations (EU) 2017/745 (MDR) and 2017/746 (IVDR).
Five years have passed since their adoption. The document is a notice to manufacturers to ensure the timely compliance of medical devices with the deadlines.
The document further explains that the MDR will fully apply to all medical devices on May 27, 2024. Therefore, manufacturers are responsible for ensuring that their devices comply with the MDR once the transition period ends.
Medical devices that have not been certified under the MDR will no longer be able to enter the EU market after that date.
CZECH REPUBLIC
CAMD Statement on the transition to MDR and the capacity of the medical device system | 20 June 2022
Following the debate on the transition to MDR and the capacity of the medical device system during the French Presidency of the EU Council, the CAMD (Committee of Competent Authorities for Medical Devices) adopted a statement at its 50th plenary session. The statement can be found here.
1. CAMD is aware of the significant and pressing issues in establishing enough capacity and preparedness for all stakeholders with proper regulatory infrastructure by May 2024. So far, the research reveals that there are various causes and no single remedy. Finding solutions is a collaborative effort.
2. CAMD recognises that if these issues are not resolved promptly, they may cause disruptions in the supply of products to health systems and patients and impede the introduction of novel medical devices into the European market.
3. When addressing urgent capacity concerns, the CAMD believes it is equally critical to explore and resolve root causes.
Relocation of seminar on Obligations of custom-made ZP manufacturers under Regulation (EU) 2017/745 of the European Parliament and of the Council | 07 June 2022
Due to a low number of participants, the seminar “Obligations of makers of custom-made ZP according to Regulation (EU) 2017/745 of the European Parliament and of the Council” scheduled for 16.6.2022 has been postponed to September 2022.
The new seminar date will be announced well in advance, and those who have already registered will be contacted personally.
Performance studies on Register of Medical Devices | 30 May 2022
With regard to the postponed launch date of the EUDAMED database, the IVDR includes transitional provisions that allow the use of the Register of Medical Devices (hereinafter referred to as “RZPRO”) for agendas that will be carried out in the future through the EUDAMED database.
These transitional provisions for IVDR provide that, until the performance study module is fully operational, the RZPRO shall be used for the application, notification and registration of SFZs, the notification of substantial changes and the reporting of serious adverse events arising during the SFZ.
The new SFZ reporting module has already been launched in RZPRO and can already be used for these purposes. Notification of SFZ will be carried out from the effective date of the IVDR according to the requirements of this legal regulation.
This also impacts the reporting of performance studies (from now on referred to as “SFZ”).
FINLAND
Presentations on clinical investigations of medical devices have been published on Fimea’s website | 1 June 2022
On May 17, 2022, Fimea hosted a research webinar to address the changes brought about by new EU laws to the application and notification processes, application materials, and clinical assessment of medical devices and in vitro diagnostic medical devices.
Other subjects covered were national legislative requirements and Fimea regulations for clinical investigations and performance studies conducted in Finland.
The webinar presentations, as well as the questions and answers posted on the chat forum during the webinar, are now available on Fimea’s website and can be accessed here.
IRELAND
CAMD publish plenary meeting statement and certificates of free sale Q&A document | 22 June 2022
The Competent Authorities for Medical Devices (CAMD) issued a statement regarding the transition to the Medical Devices Regulation (MDR) and the capabilities of the medical device system.
In this statement, the CAMD:
(1) Recognizes the urgent challenges relating to sector capacity and readiness ahead of May 2024 (notified body certificates issued in accordance with previous directives will become void from this date), which, if left unaddressed, may affect the supply of critical and innovative devices to the EU market.
(2) Outlines their commitment to collaborate with EU colleagues and key stakeholders to find solutions to these difficulties and avert supply interruptions.
(3) Agrees that solutions should focus on getting producers on the right track to compliance rather than reinterpreting MDR requirements or derogations given by national competent authorities.
(4) Requests that work on finding answers to these problems be expedited.
HPRA Guide on the Performance Studies Conducted in Ireland | 16 June 2022
This HPRA Guidance is intended to assist sponsors and other stakeholders in preparing to implement the IVDR’s Performance Study (PS) requirements. Performance studies are regarded to be carried out in the Republic of Ireland if the study:
- site is based in the Republic of Ireland,
- participants/specimens originate from the Republic of Ireland.
In general, several PS in Ireland require an application or notification to the HPRA under the IVDR. Section 3 has further information.
It is worth noting that some PS require two forms of review, one from a National Competent Authority for in vitro diagnostic medical devices and another from a relevant Research Ethics Committee.
In Ireland an ethics opinion can be sought from the National Office for Research Ethics Committees; further information can be found on the NREC website (www.nrecoffice.ie)
HPRA notification on Substantial Modification of a Clinical Investigation of a Medical Device| 08 June 2022
If the sponsor wishes to make changes to a clinical investigation in Ireland that are likely to have a significant impact on the subjects’ safety, health, or rights, or on the robustness or reliability of the clinical data generated by the investigation, they must notify the HPRA at least 38 days before implementation with notification form for substantial modification of a clinical investigation.
ITALY
Establishment of the mandatory national register for breast prosthetic implants | 03 June 2022
In the session on May 26, 2022, the State-Regions Conference expressed support for the draught decree establishing the National Register of Breast Prosthetic Implants.
Regional and provincial registries will feed the national breast implant registry. The registry will contribute to the independent assessment of the safety and long-term performance and traceability of breast implants throughout the national territory.
Regional and provincial registries will feed the national breast implant registry. The register will aid in the impartial assessment of the safety, long-term performance, and traceability of breast implants across the country.
The record will allow the regions and autonomous provinces to conduct clinical monitoring of the patient receiving implantation and recall him if necessary or subject him to specific follow-ups.
UNITED KINGDOM (UK)
UK to strengthen regulation of medical devices to protect patients| 26 June 2022
The MHRA has issued a press release outlining intentions to strengthen medical device regulation to increase patient safety and foster innovation. The MHRA intends to modernise medical device regulation to improve patient health and foster innovation.
The UK is seizing the opportunities provided by leaving the EU to bring forward new legislation that goes further to improve people’s health. The UKCA label will be used to indicate that products have met these world-class requirements.
MHRA joins international partnerships to set global standards for medicines and medical devices regulation| 16 June 2022
The MHRA announced its acceptance as a full member of three international work-sharing partnerships. In the press release issued by MHRA, intentions to strengthen medical device regulation to increase patient safety and foster innovation is outlined. Through these collaborations, the MHRA will share experience with other prominent organisations, assist in the development of regulatory guidelines, and promote better regulatory harmonisation around the world.
UNITED STATES OF AMERICA (USA)
Establishment Registration and Device Listing for Manufacturers and Importers of Devices | 23 June 2022
The Office of Management and Budget (OMB) has received a proposed collection of information from the Food and Drug Administration (FDA) for evaluation and clearance in accordance with the 1995 Paperwork Reduction Act. Medical device establishment owners and operators must electronically submit establishment registration and device listing information in accordance with section 510 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 360) and its implementing regulations in 21 CFR part 807, subparts A through D.
To achieve several statutory and regulatory objectives, such as:
- identifying establishments manufacturing marketed medical devices.
- identifying establishments manufacturing a specific device when that device is in short supply or is required for a national emergency.
- facilitating recalls for devices marketed by owners and operators of device establishments; and
- identifying an establishment that produces a specific device, complete and accurate registration and listing information is required.
- managing post-marketing surveillance programmes for devices.
- identifying those that have been illegally promoted.
- identifying and controlling those that have been imported from outside; and
- arranging inspections of registered businesses in accordance with section 704 of the FD&C Act.
Guidance on Non-Clinical Performance Assessment of Tissue Containment Systems Used During Power Morcellation Procedures | 21 June 2022
The FDA’s suggestions for non-clinical performance testing to support premarket submissions for gynaecologic and general laparoscopic power morcellation containment systems are included in this draft guidance document. These are used during laparoscopic (minimally invasive) surgeries to cut tissue into smaller pieces so that the tissue can be removed through a small incision site. It may also assist manufacturers in adhering to the special controls for non-clinical performance data for these devices. This advice offers suggestions on:
- test procedures,
- test parameters, and
- test acceptance standards and is applicable to tissue containment systems utilised during a power morcellation operation for both gynaecologic and general application.
The recommendations are meant to encourage uniformity and allow effective consideration of applications for general and gynaecologic laparoscopic power morcellation containment systems. The suggestions are being made to make sure that non-clinical test methods can efficiently uncover safety risks connected to damage to the tissue containment system and subsequent leakage of any cancer cells and other contents.
Additionally, the FDA is advising manufacturers to provide more precise information on the risks of usage as they pertain to age, the danger of spreading both benign and malignant uterine tissue, and the use of LPM containment systems in the labelling for these devices. The product labelling guidance are meant to supplement, not to replace, the doctor-patient conversation about the advantages and disadvantages of using LPMs that are particular to each patient.
Information about Consensus Standards | 07 June 2022
The Federal Food, Drug, and Cosmetic Act (FD&C Act) and Title 21, Code of Federal Regulations (21 CFR), Parts 1-58, 800-1299, both contain regulatory rules that apply to medical devices marketed in the US. The risk associated with the device determines the regulatory controls required to ensure a reasonable assurance of safety and efficacy, as well as the marketing channels. Premarket Notification (510(k), De Novo Classification Request, Exempt, Premarket Approval (PMA), Product Development Protocol, Humanitarian Use Exemption, and Biologics License Application are some of the marketing channels (BLA).
A device can be commercialised in four steps:
- Classify your device and comprehend the relevant regulatory controls.
- Select and complete the appropriate premarket submission
- Send your Premarket Submission to the FDA and Communicate with FDA Staff During Review
- Comply with Applicable Regulatory Controls, Including the Establishment Registration and Device Listing.
BRAZIL
Update of instructions for use of medical devices: understand| 06 June 2022
Updates to instructions for use resulting from needed approval changes should be posted to the medical device document repository only when the appropriate change requests have been approved and published.
Regularization processes for products that obtain updated instructions for use with information originating from requests for modification of approval necessary prior to their approval and publishing indicate an irregularity in the product registration process. As stated in Article 6 of The Collegiate Board Resolution (RDC) 431/2020, “companies that submit information that does not conform with current legislation and consistency with the regularised product are liable to the penalties set for in Law No. 6,437/1977.”
Anvisa technical note on ozone therapy technology in medical devices| 06 June 2022
Anvisa has received multiple requests for the regularisation of medical devices emitting ozone for a variety of purposes. In this regard, the Agency has recently issued a technical comment on ozone therapy technology used in medical devices.
The document includes the Agency’s current list of indications for medical equipment. This includes:
- Dentistry: antimicrobial action in the treatment of dental caries
- Periodontics: prevention and treatment of inflammatory/infectious conditions
- Endodontics: potentiation of the sanification phase of the root canal system
- Dental surgery: aid in the process of tissue repair;
- Aesthetics: aid in skin cleansing and asepsis;
Anvisa webinar addresses software regularization as a medical device| 01 June 2022
On June 13th, 2022, Anvisa hosted a virtual seminar to highlight the key topics of The Collegiate Board Resolution (RDC) 657/2022, which provides for the regularisation of software as a medical device (Software as a Medical Device – SaMD). Participants will be able to clear up any misconceptions about the subject of software regularisation.
New standard on CBPF medical devices comes into force| 01 June 2022
Anvisa informs that the Resolution of the Collegiate Board (RDC) 687/2022, which specifies the conditions for granting or renewing the Certification of Good Manufacturing Practices (CBPF) of medical devices, goes into effect on 01st June 2022. RDC 183/2017 is superseded by this standard. Furthermore, the new resolution intends to clarify the issues frequently presented by the former norm, such as those regarding plant plants susceptible to certification. Another innovation is the publishing of Anvisa’s risk matrix utilised in the certification process, which attempts to increase transparency and predictability in the productive sector.
AUSTRALIA
Post-market review of antigen and rapid antigen tests| 22 June 2022
The TGA is reviewing all COVID-19 specific laboratory antigen tests and rapid antigen tests (RATs), including point-of-care and self-tests, included in the Australian Register of Therapeutic Goods (ARTG). With ongoing work to evaluate their capacity to identify newly developing variants, the review’s goal is to ascertain whether tests have been impacted by the known variations of SARS-CoV-2 at this time.
All point of care (PoCT) and self-test RATs included in the ARTG are also subjected to laboratory testing as part of the post-market evaluation to confirm their effectiveness in identifying the Delta and Omicron variants (and other emerging variants of concern).
SARS-CoV-2 virus mutations result in a variant of the virus, which may change the structure of the produced viral protein. Test kits can then lose their ability to accurately identify the virus, producing false-negative results.
Manufacturers of these tests have given the TGA study data, including recombinant protein studies, live virus studies, inactivated virus studies, and clinical studies, to validate the effectiveness of their test kits.
TANZANIA
Notice to traders of treatment equipment on use of customer accounts when applying permits through the system – online portal| 06 June 2022
TMDA notified the medical devices purchasers about the checking of their accounts for medical devices and reagents they have registered in the TMDA accreditation application system, which is accessible at mis2.tmda.go.tz/portal.
It was discovered throughout the review that some consumers had been using several accounts on the system. Due to the customer’s inability to see their registered products on the system, they choose to send the request in a customised order, which slows down the application processing and ultimately delays the issue of permits.
Customers who have several accounts must advise TMDA of which accounts should be used and which ones should be closed before June 30, 2022. To send the information, use the email address [email protected].
In order to guarantee their quality, safety, and efficacy, the Authority also wants to implore all of its clients who purchase medical supplies and reagents to register their goods before they are imported.
SAUDI ARABIA
Updates on the compliance timeframe for Unique device identification in Saudi Arabia| 06 June 2022
The latest guidance from SFDA on unique device identification requirements (Saudi-DI) for medical devices mentions the timeframe for the implementation of UDI on the various device classes. Saudi has released the SFDA UDI database for all medical devices. The below table shows the compliance dates that must be followed.
| Compliance timeframe | |
| Launching the UDI database and starting optional registration | 01 October 2020 |
| Risk Class | Compliance date |
| Class D | 01 September 2023 |
| Class B and Class C | 01 September 2023 |
| Class A | 01 September 2024 |
BAHRAIN
Mandatory of using QR code for reporting Medical Devices complaints| 29 June 2022
In this circular, the National Health Regulatory Authority ( NHRA ) emphasises the importance of using the QR code and placing it in a prominent location for simple reporting of medical device complaints in order to ensure the quality of medical devices and the safety of patients and users. This is to ensure the safety of their use and maintenance in order to ensure patient safety.
INDIA
Classification of Dental, Obstetrical and Gynaecological Under the provision of Medical Devices Rules 2017| 06 June 2022
Safety, quality, and performance of medical devices are regulated under the provisions of the Drugs and Cosmetics Act, 1940. The list of dental products now regulated under the Medical device rules 2017 is given in this document and the Obstetrical and Gynecological products can be accessed here.